Statins are medications that lower cholesterol by inhibiting an enzyme involved in its production by the liver and other organs. First approved by the FDA in 1987, statins are arguably the most widely-prescribed medicine in the industrialized world today -- and the most profitable, representing billions a year in profits to the drug industry. In fact, Lipitor was the world's best-selling drug until its patent expired recently. Yet most trials that prove statins' effectiveness in preventing cardiac events and death have been funded by companies and principle investigators who stand to benefit from their wide use. In February, the FDA warned that statins can increase users' risk of Type 2 diabetes and memory loss, confusion and other cognition problems.

Barbara H. Roberts, M.D., is director of the Women's Cardiac Center at the Miriam Hospital in Providence, R.I. and associate clinical professor of medicine at the Alpert Medical School of Brown University. She spent two years at the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH), where she was involved in the first clinical trial that demonstrated a beneficial effect of lowering cholesterol on the incidence of heart disease. In addition to The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs, she is also author of How to Keep From Breaking Your Heart: What Every Woman Needs to Know About Cardiovascular Disease.

Martha Rosenberg: Statins have become so popular with adults middle-aged and older in industrialized countries, they are almost a pharmaceutical rite of passage. Yet you write in your new book there is little evidence they are effective in many groups and no evidence they are effective in one group: women without heart disease. Worse, you provide evidence, including stories from your own patients, that they are doing serious harm.

Barbara Roberts: Yes. Every week in my practice I see patients with serious side effects to statins, and many did not need to be treated with statins in the first place. These side effects range from debilitating muscle and joint pain to transient global amnesia, neuropathy, cognitive dysfunction, fatigue and muscle weakness. Most of these symptoms subside or improve when they are taken off statins. There is even growing evidence of a statin link to Lou Gehrig's disease.

Martha Rosenberg: One patient you write about caused a fire in her home by forgetting that the stove was on. Another was a professor who experienced such memory loss on a statin he could no longer teach; others ended up in wheelchairs. The only thing more shocking than the side effects you write about is the apparent blindness of the medical establishment to them. Until half a year ago, there were practically no warnings at all.

Barbara Roberts: There is no question that many doctors have swallowed the Kool-Aid. Big Pharma has consistently exaggerated the benefits of statins and some physicians used scare tactics so that patients are afraid that if they go off the statins, they will have a heart attack immediately. Yet high cholesterol, which the statins address, is a relatively weak risk factor for developing atherosclerosis. For example, diabetes and smoking are far more potent when it comes to increasing risk.

Martha Rosenberg: One group you say should not be given statins at all because there is no benefit and significant risk is women who have no heart disease.

Barbara Roberts: In three major studies [1-3] of women without diagnosed heart disease, but who were at high risk (in one of these studies, each participant had to have high blood pressure and three other risk factors), 40 women out of 4,904 on statins had either a heart attack or cardiac death, compared to 44 women out of 4,836 on placebo. That is not a statistically significant difference. Since the likelihood of experiencing a statin side effect is about 20 to 25 percent, the risk of putting a healthy woman on a statin far outweighs the benefit. Still, statins are routinely given to this group because the guidelines are shaped by Big Pharma. The guidelines are not supported by the evidence, and in the case of healthy women I don't follow them.

Martha Rosenberg: You give a story in your book about your 92-year-old patient who had a total cholesterol of 266, triglycerides of 169, HDL cholesterol of 66, and LDL cholesterol of 165. Her primary care doctor wanted her to take a statin, but you did not feel she needed to because she had no evidence of heart disease, had never smoked, did not have high blood pressure and was not diabetic.

Barbara Roberts: Yes and today she is 103.5 -- and doing fine, never having taken a statin.

Martha Rosenberg: In The Truth About Statins you explain pretty clearly how studies have made statins look more effective and safer than they are. How has this been done?

Barbara Roberts: First of all, the studies are of short duration, and some of them even have a "run in" phase during which people are given the drug to see if they tolerate it. If not, they are not enrolled in the study. Secondly, study subjects are cherry-picked to exclude the very elderly, people with liver or kidney disease or those with any chronic illness that might "muddy" the results --

Martha Rosenberg: In other words, the very people who will be taking them?

Barbara Roberts: Yes, and of course patients will also be staying on the drugs for life unlike trial subjects. Then, the data from the studies are usually given in terms of relative rather than absolute risk. The absolute risk of a cardiac event is only reduced by a few percentage points by statins and in some patients, like the women without heart disease we just talked about, the reduction is not even statistically significant. In some studies surrogate endpoints like inflammation or artery thickness are used but a favorable change in surrogate markers does not always translate into clinical benefit. In addition, many studies use composite end points, which include not only "hard" end points like heart attack or death (which are pretty hard to misdiagnose) but also "softer" end points like the "need" for revascularization or the occurrence of acute coronary syndromes. For example, studies may be performed in many countries with very different rates of revascularization procedures, making use of this as an end point very problematic.

Martha Rosenberg: This brings to mind the JUPITER trial, which enrolled people without heart disease, with normal levels (less than 130) of LDL or bad cholesterol, but evidence of increased inflammation as measured by the hsCRP test and treated them with placebo or rosuvastatin. JUPITER stood for "Justification for the Use of Statins in Prevention," and both the study and its principle investigator were funded by AstraZeneca, who makes the statin Crestor. The principal investigator also holds the patent for the hsCRP blood test. Why was JUPITER regarded as medical science and not marketing?

Barbara Roberts: Actually, the JUPITER study was criticized to some extent. But you have to remember that medical journals depend upon Big Pharma for their ads and reprint orders just as medical centers and medical professionals rely on Big Pharma for funding. It is a round robin situation that probably won't change until the patients, doctors and the public demand change. As for CRP, it can also rise if a patient has a cold, bronchitis or is taking post-menopausal hormones.

Martha Rosenberg: You are very outspoken about the problem of industry shaping and influencing medical practice, yet you also admit that you accepted Big Pharma money yourself.

Barbara Roberts: In 2004, Pfizer asked me to become a speaker, specifically on Lipitor. I told the drug rep who invited me to be a speaker that I would be interested in giving talks on gender-specific aspects of cardiac disease, but not in just talking about their statin, and I gave lectures in restaurants and hospitals. Despite the fact that Pfizer was sponsoring my talks, I never failed to point out that there was no evidence that Lipitor -- or any statin -- prevented cardiac events in women who did not have established cardiovascular disease. They tolerated this until one day a regional manager came to one of my talks, and then I was disinvited. I was on the speaker's bureau for another company, Abbott, but when they began to insist that I use their slides rather than my own, I gave up being on any Big Pharma speaker's bureaus. I write in my book that even though my interactions with drug and device companies complied with ethical guidelines it does not mean I was not influenced.

Martha Rosenberg: In journalism, when a reporter takes money from someone she is writing about, she is regarded as no longer a reporter but a publicist. Yet doctors who consult to Pharma are not judged as harshly and most contend they are not influenced by industry money...

Martha Rosenberg: I was surprised to find recipes in your book and even more surprised by some of your dietary recommendations, such as avoiding a low-fat diet and eating a lot of olive oil. A lot of experts have recommended a low-fat diet.

Barbara Roberts: The first thing I prescribe to my patients who have low levels of the "good" or HDL cholesterol is two to three tablespoons of olive oil a day, and in every case the HDL increases. Olive oil is rich in polyphenols, which have anti-inflammatory and antioxidant effects. Several studies [4-5] have shown that the Mediterranean diet reduces total mortality and especially death from cardiovascular disease, yet it gets little media attention. The Mediterranean diet is a plant-based diet that includes colorful vegetables, fruits, whole grains, beans, cheese, nuts, olive oil, seafood, red wine with meals, and very little meat.

Martha Rosenberg: You indict professional medical associations like the American Heat Association (AHA) for profiteering at the public's expense by calling harmful foods healthful in exchange for corporate money.

Barbara Roberts: For years, the AHA preached the gospel of the low-fat diet, calling it the "cornerstone" of its dietary recommendations though there was, and is, no evidence of its benefit. The AHA rakes in millions from food corporations for the use of its "heart-check mark." Some of the so-called heart-healthy foods it has endorsed include Boar's Head All Natural Ham, which contains 340 milligrams of sodium in a two-ounce serving, and Boar's Head EverRoast Oven Roasted Chicken Breast, which contains 440 milligrams of sodium in a two-ounce serving. High sodium intake raises blood pressure, which increases the risk of cardiovascular disease. In addition, studies have shown that eating processed meat increases the risk of diabetes and atherosclerosis.

Martha Rosenberg: You are not afraid to express strong opinions. You say that the AHA has "sold its soul," that medical centers conducting drug trials for Big Pharma have become "hired hands" and that one university medical center is Big Pharma's "lapdog." Are you afraid of retaliation from Big Pharma, medical centers or the colleagues you work with?

Barbara Roberts: I haven't received any communiqués from Big Pharma. A few colleagues have expressed dismay, but I am thick-skinned and hard-headed and don't care what they say. My main concern is the health and safety of my patients.